CClinicalTrials.gg
Sign In
Not yet recruitingNCT07456761Updated Apr 2, 2026

Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery

An interventional study of Pregabalin retard 82.5 mg and Pregabalin retard 165 mg in Laparoscopic Abdominal Surgeries, sponsored by South Egypt Cancer Institute. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.

The main questions it aims to answer are:

Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?

Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.

Participants will:

Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation

02

Conditions studied

  • Laparoscopic Abdominal Surgeries

Keywords

  • Pregabalin
  • Pain scores
  • Total opioid consumption
  • Laparoscopic abdominal surgery
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-75 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
  • Ability to understand the NRS pain scale and the study procedures
  • Written informed consent obtained

Exclusion criteria

Exclusion Criteria:

  • Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
  • Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
  • Regular use of gabapentin or pregabalin within 30 days
  • Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or on dialysis
  • Severe hepatic impairment (Child-Pugh C)
  • Uncontrolled epilepsy or other major neurological disorder
  • Severe psychiatric disease, alcohol or substance abuse
  • Pregnancy or breastfeeding
  • Planned postoperative ICU admission for reasons other than routine overnight monitoring
  • Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Group I (Low dose)

    Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia.

    Drug: Pregabalin retard 82.5 mg

  • Active comparator
    Group II (High dose)

    Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct

    Drug: Pregabalin retard 165 mg

Interventions

  • DrugPregabalin retard 82.5 mg

    Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

  • DrugPregabalin retard 165 mg

    Oral Administration 1-2 hours before elective laparoscopic abdominal surgery

05

What researchers measure

Primary outcomes

  1. Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours

    Time frame: 24 hours

Secondary outcomes

  1. Postoperative pain intensity

    Visual Analog Scale (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).

    Time frame: 2-24 hours postoperative

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07456761
Lead sponsor
South Egypt Cancer Institute
Responsible party
Muhammad Gamal Thabet Ahmed (Lecturer of anesthesia, intensive care medicine and pain therapy, South Egypt Cancer Institute) — Principal investigator
First posted
Mar 6, 2026
Start date
Apr 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

South Egypt Cancer Institute

Start the discussion